Bristol-Myers Squibb ($BMY) is again beefing up its manufacturing operations in Puerto Rico, this time to increase capacity for producing cardiovascular and Type 2 diabetes drugs.The Big Pharma company will lay out $165 million to expand its Humacao plant. Bristol-Myers will start with the addition of 82,000 square feet of new manufacturing space, and then follow up by renovating 83,150 square feet of existing space. The company will add 100 new jobs once the project finishes in 2016.Despite recent layoffs and regulatory scrutiny of manufacturing on the Caribbean island, Bristol-Myers likes it for manufacturing. "Puerto Rico's highly skilled workforce has contributed significantly to our existing operation and plays an important role in our company's future growth," said Ricardo Zayas, senior vice president of pharmaceutical manufacturing, in a statement.Reports of low-quality operations have painted a poor picture of some Puerto Rican drug manufacturing in recent years. GlaxoSmithKline ($GSK), Pfizer ($PFE), and Johnson & Johnson ($JNJ), in addition to BMS, have all had problems there. In 2007, BMS and GSK shuttered Puerto Rican plants, laying off hundreds in the process. Two years ago, Bristol-Myers had a run-in with the FDA over poor manufacturing practices at its Manati plant, which it resolved last summer.The Humacao expansion marks the second significant project for Bristol-Myers on the island. In 2009, it spent $200 million to expand its Manati facility.- here's the Bristol-Myers statementRelated Articles:
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Friday, 13 July 2012
Pharmaceutical Manufacturing-Plant Expansion-Pharma Company-Puerto Rican
Sunday, 8 July 2012
Corporate Integrity Agreement-Manufacturing Processes-Gsk
For the last two years leading up to last week's extensive settlement with U.S. authorities, GlaxoSmithKline ($GSK) already has been operating under an agreement that gives the Office of Inspector General in the Department of Health and Human Services broad authority over its manufacturing processes. The requirements are in addition to any company's usual obligations to the FDA and the agreement lays out a financial price tag if the U.K. company runs afoul of it.The provisions of the agreement are tied to deep problems at GSK's Cidra, Puerto Rico plant, which was closed in 2009. The problems, which included using tainted water in processes and mixing products in packaging, came to light in the whistleblower lawsuit brought by Cheryl Eckard, a former quality assurance manager with GSK. In October 2010, GSK agreed to pay the government $750 million to settle civil and criminal charges that it manufactured and sold adulterated drug products to Medicaid and other government health plans. The details of the compliance program have now been made public and became Appendix D to the Corporate Integrity Agreement GSK signed as part of its $3 billion settlement announced last week."This is the first time that the government, as part of a Corporate Integrity Agreement, has required a pharma company to establish a formal program to provide ongoing oversight, including Board oversight, of product released to the market to ensure that it is not adulterated," Lesley Ann Skillen, a partner in the law firm of Getnick & Getnick, who settled a related whistleblower case against Glaxo in 2010, says in an email.The oversight program is run through the "Global Manufacturing and Supply business unit" (GMS) and essentially applies to all of its manufacturing operations and employees globally. It is centered at GSK's plant in Zebulon, NC, because employees there "are responsible for the release and post-release management of all Covered Products" manufactured by the company.The program establishes a code of conduct, which employees are schooled in and must sign. It is overseen by a "GMS compliance officer" that can't be the CFO or the General Counsel of the company or subordinate to them. The compliance officer and the president of the GMS unit are the co-chairs of a compliance committee that meets quarterly to make sure the company is meeting all of its obligations. They report at least quarterly to the GSK board of directors. Board members then must sign agreements that are sent to the inspector general that the company is complying with all cGMP requirements or explain why not. The agreement also permits the FDA to complain to the inspector general if the agency believes GSK is not adequately responding to its directives.The Cidra plant was closed in 2009, 7 years after Eckard first complained to her superiors about a host of problems. In an interview last year with CBS 60 Minutes, Eckard said, "All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career." She said tainted water was used in manufacturing, production lines were turning out too-potent or not-potent-enough drugs, employees were contaminating products and different medications were packed into the same bottles.In her email, Skillen points out, "When Cheryl Eckard reported her concerns about the Cidra plant to the compliance department in 2003, they covered it up. If GSK were to do that now, it could face exclusion from Medicare and Medicaid under this CIA. That should provide a powerful incentive for GSK to do heed warnings they receive from their own employees. That's why it's an important document for GSK and an object lesson for the industry: ignore whistleblowers at your peril."The GSK agreement may have served as a blueprint for the 5-year consent decree that Ranbaxy Laboratories announced earlier this year to settle manufacturing and data reporting problems found at three o read more..
Thursday, 28 June 2012
Biopharmaceutical Company-Herborium Group Reports-Phase 2 Clinical Trial-Mycobacteria
BIRMINGHAM, Ala., June 27, 2012 /PRNewswire/ -- On June 5, 2012, Med Centro became the first SuccessEHS client in Puerto Rico to go live with the SuccessEHS solution, expanding the vendor's existing coverage in 48 states and the Virgin Islands.The go-live on June 5 took place... read more..
Insmed Announces First Patient Dosed in TARGET-NTM Phase 2 Clinical Trial of ARIKACE® in Patients with Non-Tuberculous Mycobacteria (NTM) Lung Disease
MONMOUTH JUNCTION, N.J., June 27, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the first patient has been dosed in the Company's U.S. phase 2 clinical study of ARIKACE® (liposomal amikacin for inhalation) in... read more..
Herborium Group Reports Record 6 Month Revenues
FORT LEE, N.J., June 27, 2012 /PRNewswire/ -- Herborium Group, Inc., ( HBRM) www.herborium.com, a Botanical Therapeutics® Company announces today that its revenues from AcnEase®, all botanical, proprietary acne treatment, grew over 25 percent in the first ... read more..
Wednesday, 14 March 2012
Fajardo, Puerto Rico-Birth Control Pills-Fda Warning Letter-Test Specification-Ethinyl Estradiol
In what appears to be another pregnancy risk to women taking birth control pills, the FDA has sent a warning letter to Warner Chilcott ($WCRX) saying that for 5 years the potency of its Ovcon pills has been in question.The letter follows an inspection last summer of the company's manufacturing plant in Fajardo, Puerto Rico. The FDA says that from 2006 until a recall in June 2011, "7 of 9 lots of Ovcon (Norethindrone (NE) 1 mg and Ethinyl Estradiol (EE)) 50 mcg tablets, laced on stability, failed to meet the assay test specification for Ethinyl Estradiol (EE) at different stability testing intervals." Because of this situation, the pills may not last until the expiration date, the FDA says.The company has told the FDA that it didn't take action because it believes that another test on stability condition was a more appropriate indicator. However, the FDA says Warner is required to see that a drug passes both tests. The company also has said new packaging should help, but the FDA letter says a batch in the new packaging also failed a test.This disclosure comes shortly after Glenmark Generics recalled 7 lots of norgestimate and ethinyl estradiol tablets manufactured in India, because the pills are rotated 180 degrees in the card. That announcement came about a month after Pfizer ($PFE) recalled a million packages of Lo/Ovral-28 pills and their generic counterparts for a similar packaging mishap. That event already has attorneys trolling for clients. In both cases, it was a consumer who noticed that something was wrong with the packaging.- check out the FDA warning letterRelated Articles:
Birth control redux: Glenmark Generics pulling mixed-up pills
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